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Generic Tripedia

Certain laws prevent generic biologic medications (including generic Tripedia) from being manufactured. However, recent legislation is aimed at changing these laws. If these laws change, it is expected that generic versions of Tripedia would become available in the near future.

Is a Generic Version of Tripedia Available?

Tripedia® (DTaP) is a routine childhood vaccine that provides protection against diphtheria, tetanus, and whooping cough (pertussis). It is made by Sanofi Pasteur, Inc.
 
Tripedia is different from Sanofi Pasteur's more recent DTaP vaccine Daptacel® in that it contains three pertussis antigens (instead of five), contains a trace amount of thimerosal (Daptacel has none), and is made using bovine (cow) components. Another key difference is that Tripedia is approved to be mixed with ActHIB®, a Haemophilus influenzae type b vaccine (Hib vaccine), while Daptacel is not.
 
There are no generic versions of Tripedia. There are several other DTaP vaccines on the market (some with just DTaP; some combined with other vaccines). However, none of them are technically equivalent to Tripedia, and none of them are generic vaccines.
 

Understanding Generic Vaccines

When the patents for regular drugs expire, manufacturers can apply to make generic versions. These companies need to submit a little information proving that their product is equivalent to the brand-name drug, but they do not have to repeat all of the human studies that show the drug to be safe and effective.
 
Human studies are expensive and time-consuming, and generic medications are less expensive because they do not need all of the human studies.
 
However, because vaccines are biologics (medications made using live cells or organisms, also known as "biopharmaceuticals"), they are regulated under a different set of laws. Under these laws, there is no way for a generic biologic to be approved, unless the generic manufacturer completes all of the human studies necessary to approve a brand-new drug.
 
Because such studies are extremely expensive, it is likely that a generic biologic would not be any less expensive than the brand-name product. Essentially, if a generic biologic were to be approved, it would not really be a generic, but a new and separate drug that would not be equivalent to the brand-name product.
 
However, recent legislation is aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.
 
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Tripedia Vaccine Information

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